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FDA 510(k) Application Details - K021473
Device Classification Name
System, Thermal Regulating
More FDA Info for this Device
510(K) Number
K021473
Device Name
System, Thermal Regulating
Applicant
AUGUSTINE MEDICAL, INC.
10393 WEST 70TH ST.
EDEN PRAIRIE, MN 55344 US
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Contact
SCOTT D AUGUSTINE
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Regulation Number
870.5900
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Classification Product Code
DWJ
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More FDA Info for this Product Code
Date Received
05/08/2002
Decision Date
07/09/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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